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Procedure

Esophageal Cooling During Ablation for Atrial Fibrillation (IMPACT II Trial)

N/A
Recruiting
Led By David Callans, MD
Research Sponsored by Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All AF patients deemed suitable for AF ablation treatment (under general anaesthetic) as per international guidelines and the patient has already decided on AF ablation treatment and are waiting for this procedure.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.
Awards & highlights

IMPACT II Trial Summary

This trial will test if a cooling probe can protect the oesophagus during ablation, reducing the risk of severe oesophageal damage in AF patients.

Who is the study for?
This trial is for AF patients suitable for ablation treatment under general anesthesia, as per guidelines. They must have already decided on this procedure and be waiting for it. It's not open to those who can't consent, can't follow up with endoscopy, are younger than 18 or older than 85, or have a history of upper GI tract bleeding or esophageal conditions that contraindicate instrumentation during ablation.Check my eligibility
What is being tested?
The study compares the safety of two probes during AF ablation: a new cooling probe designed to protect the oesophagus from heat damage versus the standard temperature monitoring probe. Participants will be randomly assigned in equal chance to receive either the new cooling probe or standard care.See study design
What are the potential side effects?
Potential side effects may include discomfort from the esophageal probe insertion and risks associated with thermal energy affecting nearby structures like the oesophagus during heart ablation procedures.

IMPACT II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am approved for and waiting for AF ablation treatment under general anesthesia.

IMPACT II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 4 times, at times: 0, 3, 6, 12 months from time of ablation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of endoscopically detected oesophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours).
Secondary outcome measures
Ability to attain procedural endpoints during AF ablation.
Fluoroscopy duration (minutes)
Incidence of clinically significant chest/gastroenterological symptoms post ablation
+3 more

IMPACT II Trial Design

2Treatment groups
Active Control
Group I: Study groupActive Control1 Intervention
Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees covering ablation of the left atrial posterior wall.
Group II: Control groupActive Control1 Intervention
Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anaesthetic. The esophageal temperature probe is sited close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).

Find a Location

Who is running the clinical trial?

Texas Cardiac Arrhythmia Research FoundationOTHER
37 Previous Clinical Trials
12,880 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
835 Previous Clinical Trials
13,006,145 Total Patients Enrolled
Royal Brompton & Harefield NHS Foundation TrustOTHER
224 Previous Clinical Trials
140,461 Total Patients Enrolled

Media Library

ensoETM. Esophageal cooling during AF ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04577859 — N/A
Atrio-Esophageal Fistula Research Study Groups: Study group, Control group
Atrio-Esophageal Fistula Clinical Trial 2023: ensoETM. Esophageal cooling during AF ablation Highlights & Side Effects. Trial Name: NCT04577859 — N/A
ensoETM. Esophageal cooling during AF ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577859 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial have an age restriction, specifically for those over 65?

"For this clinical trial, only participants of legal age and under 85 years old can be recruited."

Answered by AI

Is recruitment currently ongoing for this trial?

"As listed on clinicaltrials.gov, the recruitment of participants for this study is currently underway. This experimental trial was first opened to public scrutiny on March 10th 2022 and has recently been updated with new information as of February 15th 2023."

Answered by AI

What is the aggregate number of clinical centers administering this trial?

"Several clinical trial sites are offering this medication, such as the Beth Israel Deaconess Medical Center in Boston, University of Pennsylvania in Philadelphia, and Texas Cardiac Arrhythmia Research Foundation in Austin. An additional 5 locations can also be found across America."

Answered by AI

Can I sign up for this experiment?

"This medical trial seeks to recruit 500 individuals, aged between 18 and 85 years old, who are currently suffering from atrio-esophageal fistula. In addition, they must meet the necessary requirements for AF ablation treatment (general anaesthesia) as indicated by international standards. Moreover, participants must have already decided on undergoing this procedure prior to joining the study."

Answered by AI

What is the current count of participants in this clinical experiment?

"This trial, managed by Advanced Cooling Therapy Inc. (Attune Medical), requires 500 patients who meet the pre-set qualifications to be recruited from a range of medical centres - such as Beth Israel Deaconess in Boston and University of Pennsylvania in Philadelphia."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
~167 spots leftby Mar 2025